drugset / Trial / NCT04226066

Safety, Tolerability and Pharmacokinetics Characteristics of Recombinant Oncolytic Vaccinia Virus Injection T601 as a Single Drug or in Combination With Oral Flucytosine (5-FC), in Patients With Advanced Malignant Solid Tumors

NCT04226066

Phase 1/2 Unknown 69 enrolled Tasly Tianjin Biopharmaceutical Co., Ltd.
NaSequentialOpen-labelTreatment

Summary

This open, dose-escalation and extended PhI/IIa clinical trial aims to evaluate the safety, tolerability of T601 as a single-agent as well as combined with prodrug 5-FC to treat patients with advanced malignant solid tumors and to explore the pharmacokinetic characteristics of T601, 5-FC, 5-FU, FBAL, which includes PhI study of dose-escalation study and Ph IIa study of extending study.

Timeline

Start
2019-11-20
Primary completion
2021-05-31
Completion
2022-05-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Flucytosine Small molecule Oral
Subject T601 Unknown 1e+07 unknown
Subject T601 Unknown 3e+07 unknown
Subject T601 Unknown 1e+08 unknown
Subject T601 Unknown 3e+08 unknown
Subject T601 Unknown 1e+09 unknown

Indications